WO2011125133A1 - Joint de cylindre et seringue pré-remplie l'utilisant - Google Patents

Joint de cylindre et seringue pré-remplie l'utilisant Download PDF

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Publication number
WO2011125133A1
WO2011125133A1 PCT/JP2010/002614 JP2010002614W WO2011125133A1 WO 2011125133 A1 WO2011125133 A1 WO 2011125133A1 JP 2010002614 W JP2010002614 W JP 2010002614W WO 2011125133 A1 WO2011125133 A1 WO 2011125133A1
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WO
WIPO (PCT)
Prior art keywords
gasket
piston
cylinder
syringe
thermoplastic elastomer
Prior art date
Application number
PCT/JP2010/002614
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English (en)
Japanese (ja)
Inventor
四ッ辻晃
Original Assignee
有限会社コーキ・エンジニアリング
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 有限会社コーキ・エンジニアリング filed Critical 有限会社コーキ・エンジニアリング
Priority to PCT/JP2010/002614 priority Critical patent/WO2011125133A1/fr
Priority to JP2012509191A priority patent/JP5623508B2/ja
Publication of WO2011125133A1 publication Critical patent/WO2011125133A1/fr

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Classifications

    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J15/00—Sealings
    • F16J15/16—Sealings between relatively-moving surfaces
    • F16J15/32—Sealings between relatively-moving surfaces with elastic sealings, e.g. O-rings
    • F16J15/3284—Sealings between relatively-moving surfaces with elastic sealings, e.g. O-rings characterised by their structure; Selection of materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16J—PISTONS; CYLINDERS; SEALINGS
    • F16J1/00—Pistons; Trunk pistons; Plungers
    • F16J1/005—Pistons; Trunk pistons; Plungers obtained by assembling several pieces
    • F16J1/006—Pistons; Trunk pistons; Plungers obtained by assembling several pieces of different materials
    • F16J1/008—Pistons; Trunk pistons; Plungers obtained by assembling several pieces of different materials with sealing lips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod

Definitions

  • the present invention relates to a syringe used for administering a drug solution to a human or an animal in the medical and medical fields, particularly to a gasket for a syringe suitable for a prefilled syringe.
  • a drug solution for injection is filled in advance, transported and stored in a sealed and sealed state with a cap or the like at the tip portion to which the injection needle is attached.
  • So-called pre-filled syringes are widely used in recent years to administer the drug solution in the cylinder by pressing the piston (push rod) and sliding the gasket in the direction of the tip of the cylinder after attaching the injection needle to the tip of the cylinder It has become like that.
  • Pre-filled syringes are characterized in that they can be administered in precise amounts without misuse of the drug solution, and transfer operations of the drug solution are unnecessary, and microbial contamination etc. of the drug solution caused by such operations can be prevented. Have.
  • the gaskets are formed of butyl rubber, thermoplastic elastomer (TPE) or the like, but these rubber gaskets improve the "slipperiness" when sliding on the inner surface of the cylinder
  • TPE thermoplastic elastomer
  • the gasket 1 as shown in FIG. 5 is developed (for example, refer patent document 1).
  • the gasket 1 improves the slidability with respect to the cylinder 4 by laminating the resin film 3 on the surface of the gasket body 2 made of rubber, making it unnecessary to apply the silicone grease to the inner surface of the cylinder 4 and removing the silicone grease. It is possible to avoid the above-mentioned problems resulting from it.
  • the gasket 1 of Patent Document 1 has the following problems. That is, although the screw hole 6 for screwing the front end portion of the piston 5 is formed in the gasket body 2, the piston 5 is screwed as it is because of the poor slidability of the rubber forming the gasket body 2. Since it is difficult to screw into the hole 6, when screwing the piston 5 into the screw hole 6, it was necessary to apply silicone grease to the surface of the screw hole 6 or the tip of the piston 5.
  • the rubber has relatively large flexibility, when the piston 5 is screwed into the screw hole 6 of the gasket body 2 and then the piston 5 is pulled (for example, at the time of blood collection), the ridge 6a of the screw hole 6
  • the piston 5 may possibly come off the screw hole 6 as described above.
  • heat sterilization for example, steam sterilization at 120 ° C. for 20 minutes
  • the heat causes the gasket 1 to be deformed, causing a gap with the inner surface of the cylinder 4 to spill out the chemical solution, or conversely, the fitting state of the gasket 1 to the cylinder 4 becomes tight. There was a risk that the gasket 1 could not easily move.
  • the present invention has been developed in view of such problems of the prior art. Therefore, the main object of the present invention is, of course, that the slidability with respect to the cylinder is good, there is no need to apply silicone grease to the screw hole for screwing the piston and there is no risk of the piston coming off, and heating It is an object of the present invention to provide a syringe gasket that does not deform even when subjected to sterilization treatment, and a prefilled syringe using the same.
  • the gasket body 12 made of thermoplastic elastomer has a sliding surface and a tip surface covered with the sliding film 20 and a recess 16 is formed on the surface to which the piston P is attached;
  • the thermoplastic elastomer forming the gasket body 12 is provided with a screw hole 18 into which the tip of the piston P is screwed, and is attached to the recess 16 with the screw hole 18 opened to the outside.
  • a gasket 10 for a syringe characterized by comprising a plastic base member 14 having a high softening point.
  • the gasket main body 12 formed of a thermoplastic elastomer is required for the gasket for a syringe 10 by covering the sliding surface and the tip end surface with the slidable film 20.
  • the base member 14 is attached to the recess 16 formed in the “surface to which the piston P is attached” in the gasket main body 12 provided with “slidability and sealability with the inner surface”.
  • the base member 14 is formed of a plastic having a softening point higher than that of the thermoplastic elastomer forming the gasket body 12, and the gasket body is opened with the screw hole 18 to which the tip of the piston P is screwed. It is attached to twelve.
  • the screw hole 18 in which the piston P is screwed is formed of plastic having much better slidability than rubber, it is easy to apply the silicone grease to the screw hole 18.
  • the piston P can be screwed on.
  • the base member 14 having a softening point higher than that of the thermoplastic elastomer and the slidable film 20 are formed.
  • the base member 14 and the slidable film 20 play a role of a framework since they are firmly adhered to the gasket body 12 at times, the deformation of the gasket body 12 is prevented, and the inner surface of the cylinder C and the syringe Avoid the possibility that the chemical solution M may spill out due to a gap with the gasket 10 and conversely the tight fit of the syringe gasket 10 with the cylinder C may cause the syringe gasket 10 to not move easily. it can.
  • the invention according to claim 2 relates to the gasket 10 for a syringe according to claim 1, wherein "the gasket main body 12 is formed of a fluorine-free thermoplastic elastomer,
  • the base member 14 is characterized by being formed of any plastic material selected from high density polyethylene, polypropylene, cycloolefin polymer, and cyclic olefin-based copolymer.
  • the material of the fluorinated thermoplastic elastomer is The surface has low slidability (has adhesiveness) and is made of a base member 14 and a fluorine-based thermoplastic elastomer formed of a material other than “fluorinated plastic” such as a fluorine-containing thermoplastic resin
  • the bonding strength is extremely weak with the gasket body 12 of this type, and there is a risk that the base member 14 may be pulled out of the gasket body 12 when the piston P screwed to the base member 14 is pulled.
  • a fluorine-containing thermoplastic resin or the like Tsu fluorinated plastic "only can not be used.
  • the gasket body 12 is formed of "a thermoplastic elastomer containing no fluorine", and has a high density that adheres firmly to the "thermoplastic elastomer containing no fluorine" at the time of molding.
  • the use of polyethylene (HDPE), polypropylene (PP), cycloolefin polymer (COP), or cyclic olefin copolymer (COC) as the base member 14 does not cause the above-mentioned problems.
  • "high density” polyethylene means the thing whose specific gravity is 0.96 or more.
  • the invention described in claim 3 relates to the gasket for a syringe 10 described in claim 1 or 2, wherein "the slidable film 20 is a PTFE film, The bonding surface of the gasket body 12 and the PTFE film 20 is subjected to an adhesion improving process.
  • PTFE polytetrafluoroethylene, tetrafluoride
  • slidable film 20 covering the sliding face and tip face of the gasket body 12. Since the ethylene) film 20 is used, the slidability of the gasket for syringe 10 with respect to the cylinder C can be further enhanced, and the slide can be performed more smoothly.
  • the PTFE film 20 is poorly adhesive and the bonding strength with the “fluorine-free thermoplastic elastomer” constituting the gasket body 12 is extremely weak, the PTFE film 20 may be simply bonded to the gasket body 12. Although the intended molded product can not be obtained, in the gasket 10 for a syringe of the present invention, the bonding surface of the gasket body 12 and the PTFE film 20 is subjected to an adhesion improving treatment, so The gasket main body 12 can be firmly joined at the time of molding.
  • the syringe gasket 10 for a syringe that has extremely high slidability with respect to the cylinder C, and that there is no concern that the PTFE film 20 is detached from the gasket body 12 due to vibration or impact.
  • the cylinder C filled with the chemical solution M which seals the cylinder C. It is a prefilled syringe A having a piston P which pushes the gasket 10 for a syringe toward the tip of the cylinder C and whose tip is a screw P screwed into the screw hole 18.
  • the slidability with respect to the cylinder is good, there is no need to apply silicone grease to the screw hole for screwing the piston and there is no risk of the piston coming off, and heat sterilization treatment It was possible to provide a gasket for a syringe which is not deformed even when received.
  • FIG. 1 is a cross-sectional view showing a gasket 10 for a syringe of the present invention
  • FIG. 2 is a cross-sectional view showing a prefilled syringe A to which the gasket 10 for a syringe is applied.
  • the prefilled syringe A is generally configured of a gasket for syringe 10 (hereinafter simply referred to as “gasket 10”), a cylinder C, a piston P, and a cap K.
  • gasket 10 a gasket for syringe 10
  • cylinder C a cylinder C
  • piston P a piston
  • cap K a cap K
  • M in the figure is a drug solution (injection solution) filled in the syringe A.
  • the gasket 10 is made of PTFE (polytetrafluoroethylene, tetrafluoroethylene) laminated on the sliding surfaces of the gasket body 12, the base member 14, and the inner surface of the cylinder C in the gasket body 12. And a film 20.
  • PTFE polytetrafluoroethylene, tetrafluoroethylene
  • the gasket body 12 of the present embodiment is a thermoplastic that uses polystyrene (PS) or polypropylene (PP) as a hard segment, and ethylene propylene (EPDM), polybutadiene (BDR), or polyisoprene as a soft segment.
  • PS polystyrene
  • PP polypropylene
  • EPDM ethylene propylene
  • BDR polybutadiene
  • TPE elastomer
  • the material of the gasket body 12 is not limited to this, and other types of thermoplastic elastomers can be used.
  • thermoplastic resin does not contain fluorine, in that the cost of the gasket 10 can be stably kept low due to the wide choice of materials, and it can be easily coped with the surge of demand. It is preferred to use an "elastomer”.
  • thermoplastic elastomer having good heating permanent strain and produced by mixing and vulcanizing simultaneously may be used, and as additives for vulcanization purpose, sulfur, many Functional silicon, bismaleimides, organic peroxides, etc. can be considered.
  • the base member 14 is a substantially cylindrical member formed of a plastic having a softening point higher than that of the thermoplastic elastomer forming the gasket body 12, and a screw hole in which the tip of the piston P is screwed on the bottom surface thereof. 18 is formed and attached so as to be fitted into the recess 16 of the gasket body 12 with the screw hole 18 opened to the outside.
  • any plastic having a softening point higher than that of a thermoplastic elastomer and exhibiting high adhesion to the thermoplastic elastomer can be used, but a highly versatile high density It is preferred to use polyethylene (HDPE), polypropylene, cycloolefin polymers (COP) or cyclic olefin copolymers (COC).
  • HDPE polyethylene
  • COP cycloolefin polymers
  • COC cyclic olefin copolymers
  • the shape of the base member 14 is not limited to a substantially cylindrical shape having a slightly pointed end opposite to the surface on which the screw hole 18 is formed, as shown in FIG. 1, for example, as shown in FIG.
  • the side peripheral surface at the end on the surface side where the hole 18 is formed may be shaped so as to have a ridge 21 having a circular outer shape in plan view.
  • FIG. 3A shows an aspect in which the outer peripheral surface of the crucible 21 is covered with the PTFE film 20, and in FIG. 3B, the PTFE film 20 is disposed up to the lower surface in the drawing of the crucible 21.
  • the aspect which the outer peripheral surface of the weir 21 exposed is shown.
  • the tip of the piston P is screwed into the screw hole 18 of the base member 14.
  • the weir 21 properly guides the movement of the gasket 10, and there is no risk of the gasket 10 being pushed obliquely in the cylinder C.
  • the piston P can be more securely fixed to the base member 14.
  • the PTFE film 20 imparts high slidability to the sliding surface of the gasket main body 12 laminated on the sliding surface with the inner surface of the cylinder C in the gasket main body 12 (that is, the outer peripheral side surface of the gasket main body 12) and the tip surface. Sliding film.
  • the thickness of the PTFE film 20 is set to 20 ⁇ m or more and 80 ⁇ m or less before lamination to the gasket body 12. This makes it difficult to obtain the PTFE film 20 economically when the thickness of the PTFE film 20 is less than 20 ⁇ m, and conversely, when the thickness of the PTFE film 20 is more than 80 ⁇ m, the elasticity of the gasket body 12 is sufficient.
  • slidable films other than the PTFE film 20 may be laminated on the gasket body 12, but in view of the purpose of imparting high slidability to the gasket 10, it is preferable to use the PTFE film 20.
  • the PTFE film 20 is laminated on the gasket body 12 by injection molding as described later (the thickness of the PTFE film 20 after lamination becomes 10 ⁇ m to 20 ⁇ m), and the elasticity of the gasket body 12 is inhibited.
  • those exhibiting an elongation of at least about 250 to 650% (more precisely, elongation at break) are preferred. If the elongation rate is 300% or less, there is a risk that the PTFE film 20 may be broken at the time of molding (stretching) of the gasket 10 described later. It is more preferable to use the one having an elongation of 300% or more.
  • the PTFE film 20 can be produced by a method of forming the PTFE into a sheet using a casting method, a method of forming the PTFE into a block and slicing it with a blade, or a skiving process.
  • the PTFE film 20 has a problem that the bonding strength with the “thermoplastic elastomer not containing fluorine” is extremely weak and the bonding strength with the “thermoplastic elastomer containing no fluorine” is extremely weak.
  • chemical treatment with metallic sodium or plasma treatment in an argon atmosphere may be performed as “adhesion improvement treatment”.
  • the plasma of the PTFE film 20 is used.
  • Butadiene may be plasma polymerized on the surface.
  • BDR polybutadiene
  • the silica fine particle layer 22 is composed of a binder 22a and silica (SiO2) fine particles 22b, and the PTFE film 20 and the gasket main body 12 having a poor adhesion property due to the affinity to the gasket main body 12 and the anchor effect possessed by the silica fine particles 22b It can be joined firmly.
  • the fine silica particle 22b constituting the fine silica particle layer 22 is adhered on the surface of the PTFE film 20 in a state of being exposed to some extent from the binder 22a, and the exposed portion bites into the surface of the gasket main body 12 to exert an anchor effect. .
  • Specific examples of the method for forming the silica fine particle layer 22 on the surface of the PTFE film 20 include the following two methods.
  • the first method is a method using a PFA resin as a binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20.
  • the aqueous solution of PFA resin is mixed with the silica fine particles 22b and a surfactant.
  • the mixed dispersion obtained by stirring is uniformly coated on one side of the PTFE film 20 using a known coating method (for example, a spray method, a roll coating method, etc.), introduced into a furnace (not shown)
  • the PFA resin is fired at 250 to 360 ° C. using an apparatus capable of maintaining the shape of the PTFE film 20.
  • the PFA resin as the binder 22a is integrated with the PTFE film 20, and the silica fine particles 22b can be firmly fixed to the surface of the PTFE film 20.
  • the gasket 10 is suitably manufactured by compression molding or injection molding ( That is, it becomes possible to co-mold, and it is possible to prevent the PTFE film 20 from inhibiting the elasticity of the gasket body 12.
  • the second method is a method using a varnish in which a perfluoro fluorine resin and PFA powder are mixed as a binder 22a for fixing the silica fine particles 22b to the surface of the PTFE film 20.
  • a perfluoro fluorine resin and silica fine particles 22b is dispersed in a perfluoro solvent (for example, CT-solv. 100 manufactured by Asahi Glass Co., Ltd., etc.), and the varnish obtained is uniformly coated on one side of the PTFE film 20 using a known coating method, and dried. Heat treated to form.
  • the silica fine particle layer 22 can be efficiently formed on the surface of the PTFE film 20.
  • the thickness of the silica fine particle layer 22 formed by each method as described above is preferably in the range of 0.5 ⁇ m to 10 ⁇ m. Within this range, both can be firmly joined without inhibiting the elongation of the PTFE film 20 and the elasticity of the gasket body 12.
  • the average particle diameter of the silica fine particles 22b constituting the silica fine particle layer 22 is preferably in the range of 0.02 ⁇ m to 10 ⁇ m, and more preferably in the range of 0.05 ⁇ m to 2 ⁇ m.
  • the average particle diameter of the silica fine particles 22b is less than 0.05 ⁇ m, the handling of the silica fine particles 22b becomes difficult, and it becomes difficult to economically manufacture the silica fine particles 22b, conversely, the silica fine particles 22b
  • the average particle diameter of the silica particles 22b is larger than 10 ⁇ m, the specific surface area of the silica fine particles 22b is reduced, and a sufficient anchoring effect on the gasket body 12 can not be exhibited.
  • the cylinder C (FIG. 2) has a needle mounting portion c1 at its front end, a finger hooking portion c2 at its rear end, and a cylindrical drug solution filling portion c3 formed between them, and in this embodiment is formed of cyclic polyolefin. .
  • the shape of the cylinder C is not limited to that shown in the drawing, and polypropylene, glass or the like can also be used as the material of the cylinder C.
  • the piston P is a rod-like member having a gasket mounting portion p1 at its front end and a finger rest p2 at its rear end.
  • the gasket mounting portion p1 of the piston P is formed with an external thread to be screwed into the screw hole 18 of the base member 14 of the gasket 10 described above.
  • the piston P is also made of resin such as cyclic polyolefin, polycarbonate and polypropylene, glass, and the like.
  • the cap K is basically formed of the same material as the cylinder C, and the needle mounting portion c1 of the cylinder C is airtightly covered, and the chemical solution filled in the cylinder C undesirably leaks from the needle mounting portion c1. It has a role to prevent release.
  • the PTFE film 20 on which the layer 22 is formed is placed on the open face of the mold (FIG. 4 (b)), and after that, the thermoplastic elastomer Y which is a raw material of the gasket main body 12 is fixed in a clamped state.
  • thermoplastic elastomer adheres firmly to the PTFE film 20 through the base member 14 and the silica fine particle layer 22.
  • the pocket 10 is formed. Then, after the gasket 10 is cooled, the mold 10 is opened and taken out from the mold, and the unnecessary portion is trimmed if necessary, whereby the manufacturing of the gasket 10 is completed.
  • the screw hole 18 in which the piston P is screwed is formed of plastic having better slidability than rubber, silicone grease is applied to the screw hole 18 Instead, the piston P can be easily screwed.
  • the desired molded product can not be obtained (that is, the base member 14 having a higher softening point than the thermoplastic elastomer).
  • the PTFE film 20 laminated on the surface (sliding surface and tip surface) of the gasket body 12 plays a role of a framework to prevent deformation of the gasket body 12, and between the inner surface of the cylinder C and the gasket 10. It is possible to avoid the possibility that the chemical solution M may spill out due to a gap, or the fitting state of the gasket 10 with respect to the cylinder C may become tight and the gasket 10 may not easily move.

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  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Combustion & Propulsion (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un joint de cylindre qui a naturellement de bonnes propriétés de glissement relativement à un cylindre, qui ne nécessite pas l'application de graisse de silicium à un trou fileté dans lequel un piston est vissé, qui n'est pas susceptible de délogement du piston, et qui n'est pas déformé même s'il est soumis à une stérilisation par la chaleur. Le joint de cylindre (10) comprend : un corps principal de joint (12) qui est formé à partir d'un élastomère thermoplastique et dont les surfaces de glissement et la surface de la pointe sont couvertes d'un film de réduction de la friction (20), et a une cavité (16) formée sur la surface sur laquelle un piston (P) est monté ; et un élément de base (14) formé à partir d'un plastique ayant un point de ramollissement plus élevé que l'élastomère thermoplastique qui forme le corps principal de joint (12), ledit élément de base ayant un trou fileté (18) dans lequel la pointe du piston (P) est vissée, et ledit élément de base étant monté dans la cavité (16) avec le trou fileté (18) ouvert sur l'extérieur.
PCT/JP2010/002614 2010-04-09 2010-04-09 Joint de cylindre et seringue pré-remplie l'utilisant WO2011125133A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/JP2010/002614 WO2011125133A1 (fr) 2010-04-09 2010-04-09 Joint de cylindre et seringue pré-remplie l'utilisant
JP2012509191A JP5623508B2 (ja) 2010-04-09 2010-04-09 シリンジ用ガスケットおよびそれを用いたプレフィルドシリンジ

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PCT/JP2010/002614 WO2011125133A1 (fr) 2010-04-09 2010-04-09 Joint de cylindre et seringue pré-remplie l'utilisant

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103656803A (zh) * 2012-08-30 2014-03-26 住友橡胶工业株式会社 叠层密封垫
EP2910265A1 (fr) * 2014-02-19 2015-08-26 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité de seringue et seringue préremplie
JP2015167677A (ja) * 2014-03-06 2015-09-28 住友ゴム工業株式会社 ガラスシリンジおよびプレフィルドシリンジ
EP3006069A1 (fr) * 2014-10-10 2016-04-13 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité pour seringue préremplie
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
EP4006389A1 (fr) * 2020-11-27 2022-06-01 Cam Lock Limited Joint
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2592381A (en) * 1949-10-13 1952-04-08 Premo Pharmaceutical Lab Inc Hypodermic syringe
JPS6485665A (en) * 1987-06-19 1989-03-30 Terumo Corp Medical instrument and its preparation
JPH02106236U (fr) * 1989-02-08 1990-08-23
JP2006502896A (ja) * 2002-10-14 2006-01-26 ボーテック， ナームローゼ フェンノートシャップ 医療用シリンジのプランジャを製造する方法および器具、それによって獲得されるプランジャ、ならびに医療用シリンジ
JP2008510539A (ja) * 2004-08-24 2008-04-10 バイエル・シエーリング・ファーマ アクチエンゲゼルシャフト 注射器用のプランジャ及び注射器
JP2009505794A (ja) * 2005-08-29 2009-02-12 ウェスト ファーマシューティカル サービシズ インコーポレイテッド 注射器用デュアルマテリアルプランジャチップ

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2592381A (en) * 1949-10-13 1952-04-08 Premo Pharmaceutical Lab Inc Hypodermic syringe
JPS6485665A (en) * 1987-06-19 1989-03-30 Terumo Corp Medical instrument and its preparation
JPH02106236U (fr) * 1989-02-08 1990-08-23
JP2006502896A (ja) * 2002-10-14 2006-01-26 ボーテック， ナームローゼ フェンノートシャップ 医療用シリンジのプランジャを製造する方法および器具、それによって獲得されるプランジャ、ならびに医療用シリンジ
JP2008510539A (ja) * 2004-08-24 2008-04-10 バイエル・シエーリング・ファーマ アクチエンゲゼルシャフト 注射器用のプランジャ及び注射器
JP2009505794A (ja) * 2005-08-29 2009-02-12 ウェスト ファーマシューティカル サービシズ インコーポレイテッド 注射器用デュアルマテリアルプランジャチップ

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103656803A (zh) * 2012-08-30 2014-03-26 住友橡胶工业株式会社 叠层密封垫
EP2910265A1 (fr) * 2014-02-19 2015-08-26 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité de seringue et seringue préremplie
JP2015167677A (ja) * 2014-03-06 2015-09-28 住友ゴム工業株式会社 ガラスシリンジおよびプレフィルドシリンジ
EP3006069A1 (fr) * 2014-10-10 2016-04-13 Sumitomo Rubber Industries, Ltd. Joint d'étanchéité pour seringue préremplie
US11406565B2 (en) 2015-03-10 2022-08-09 Regeneran Pharmaceuticals, Inc. Aseptic piercing system and method
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11547801B2 (en) 2017-05-05 2023-01-10 Regeneron Pharmaceuticals, Inc. Auto-injector
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
EP4006389A1 (fr) * 2020-11-27 2022-06-01 Cam Lock Limited Joint
USD1007676S1 (en) 2021-11-16 2023-12-12 Regeneron Pharmaceuticals, Inc. Wearable autoinjector

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